ELECTROPHORESIS ACCESSORY MO. 3526
Device Facts
| Record ID | K761248 |
|---|---|
| Device Name | ELECTROPHORESIS ACCESSORY MO. 3526 |
| Applicant | Gilford Instrument Laboratories, Inc. |
| Product Code | JJN · Clinical Chemistry |
| Decision Date | Dec 21, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2485 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.
